|" . . . we are building our future on a foundation of more than a half-century of innovation and leadership in medical imaging."
A Robust and Advancing Molecular Imaging Pipeline
At Lantheus Medical Imaging, we are committed to investing in the field of diagnostic imaging and developing the next generation of imaging agents to advance patient care. With proven expertise in discovering and developing imaging solutions, Lantheus is focused on addressing the need for improved medical imaging tools and building on its foundation of pioneering research and development. Our clinical development efforts include a promising program to develop a Positron Emission Tomography (PET) myocardial perfusion imaging (MPI) agent, which is currently in Phase 3 clinical trials, as well as agents that could indentify heart failure and vulnerable arterial plaque. We believe that our next generation medical imaging tools have the potential to provide physicians with improved non-invasive and cost-effective options to help diagnose and evaluate cardiovascular disease.
About PET Technology
PET is an imaging technology that, with an appropriate radiopharmaceutical imaging agent, may provide important insights into physiologic and metabolic processes in the body. PET has demonstrated broad utility for diagnosis, prognosis, disease staging and therapeutic response. PET data are typically quantitative, and exhibit very high image resolution. PET, with an appropriate imaging agent, is useful in evaluating a variety of conditions — including heart disease, neurological disease and cancer1.
Today, most nuclear heart imaging procedures use single photon emission computed tomography (SPECT) technology. Although SPECT provides substantial clinical value, there is growing interest in the medical community to utilize PET technology that can provide meaningful advantages, including higher image quality, quantitative myocardial blood flow information, and improved diagnostic accuracy2.
PET Perfusion Agent: Flurpiridaz F 18
Flurpiridaz F 18 (formerly known as BMS747158) is a novel cardiac PET imaging agent that has the potential to be an important new clinical tool for the evaluation of cardiac blood flow in patients with known or suspected coronary artery disease (CAD). CAD is the leading cause of death in the United States for both men and women3.
In June 2011, Lantheus initiated the first of the two Phase 3 clinical trials of flurpiridaz F 18 in patients with suspected or known coronary artery disease. The initiation of the first Phase 3 trial with flurpiridaz marks a critical step in the development of this novel imaging agent.
Data from the Phase 2 trial showed that PET imaging with flurpiridaz F 18 demonstrated a positive safety profile and provided superior image quality, diagnostic certainty and diagnostic performance for detecting CAD compared to SPECT imaging, the current standard of care for the non-invasive detection of CAD. No serious adverse events attributable to flurpiridaz F 18 injection were reported in Phase 1 or Phase 2 clinical trials.
In March 2011, Lantheus received a Special Protocol Assessment (SPA) approval from the FDA for the Phase 3 trial of flurpiridaz F 18. The Phase 3 clinical development program includes two open-label, multicenter trials to assess the diagnostic efficacy (both sensitivity and specificity) of flurpiridaz F 18 PET MPI, compared with SPECT MPI in the detection of significant coronary artery disease. The trials will enroll a total of approximately 1,350 patients worldwide, including locations in the U.S., Canada, Europe and South America.
PET Cardiac Neuronal Imaging Agent: LMI 1195
LMI 1195, a fluorine 18-based PET agent designed for cardiac neuronal imaging, has completed Phase 1 clinical trials. LMI 1195 is a novel F 18 small molecule tracer that has the potential to identify patients that would benefit from implantation of an implantable cardioverter defibrillator (ICD) in order to decrease risk of sudden cardiac death (SCD).
Preliminary Phase 1 study results show that LMI 1195 has favorable safety, dosimetry and tolerability profiles. In addition, LMI 1195 provided high-quality, well-defined three-dimensional images of the autonomic nervous system of the heart. The initial data also showed that myocardial uptake of LMI 1195 was high and uniform throughout the heart and the radiotracer cleared quickly from the blood.
Vascular Remodeling Imaging Agent
We are currently exploring a non-invasive gadolinium-based MRI agent that may be useful in identifying patients at risk of sudden cardiac death due to coronary plaque rupture. We have identified a method to view and assess the coronary arterial vasculature using a compound that binds to elastin, a protein found in artery walls. In animal models, the molecule enables visualization of the full thickness of arterial walls in a magnetic resonance imaging (MRI) scan.